RIVA BOND 8800610

GUDID 09336472018245

RIVA BOND LC P/L KT

SDI LIMITED

Dentine bonding agent/set
Primary Device ID09336472018245
NIH Device Record Key9d390de3-ad4d-41e4-80f5-fc215170e04c
Commercial Distribution StatusIn Commercial Distribution
Brand NameRIVA BOND
Version Model Number8800610
Catalog Number8800610
Company DUNS753221852
Company NameSDI LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *4°C - 25°C (39 - 77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *4°C - 25°C (39 - 77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *4°C - 25°C (39 - 77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *4°C - 25°C (39 - 77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *4°C - 25°C (39 - 77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *4°C - 25°C (39 - 77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *4°C - 25°C (39 - 77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *4°C - 25°C (39 - 77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *4°C - 25°C (39 - 77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *4°C - 25°C (39 - 77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *4°C - 25°C (39 - 77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *4°C - 25°C (39 - 77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *4°C - 25°C (39 - 77°F)

Device Identifiers

Device Issuing AgencyDevice ID
GS109336472018245 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EMACEMENT, DENTAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-16
Device Publish Date2025-01-08

On-Brand Devices [RIVA BOND]

DO3688006121RIVA BOND LC LQD REF
DO3688006111RIVA BOND LC PWD REF 5G
DO3688006101RIVA BOND LC P/L KT
09336472018245RIVA BOND LC P/L KT

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